Actively Recruiting

Age: 18Years +
MALE
NCT04706663

Precision-Based Genomics in Prostate Cancer

Led by National Cancer Institute (NCI) · Updated on 2026-04-24

2000

Participants Needed

11

Research Sites

302 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Prostate cancer is the most common cancer and the second leading cause of death in males in the United States. Researchers want to find additional gene mutations that may increase a man s risk for prostate cancer and may affect how aggressive the disease is. Objective: To look at gene mutations in men with prostate cancer as well as the course of their disease to better understand how gene mutations relate to the way the cancer progresses and responds to treatment. Eligibility: Adult males 18 and older with prostate cancer who have at least one of the gene mutations researchers want to study and/or have been treated for their cancer and have had complete elimination of their cancer or stable disease for a long time. Design: Participants will be screened with a review of their medical records. Their gene test results will be reviewed, if available. They will be asked questions over the phone or in person. Participants do not need to visit the NIH for this study. But if they visit NIH for another study, their data and test results will be collected. They may give blood and urine samples. They may give leftover tumor samples. These samples will be used to study their genes. Participants who do not come to NIH on regular basis will be contacted every 6 months by phone or e-mail. They will be asked questions about their health. Data from their medical records will be collected. Participants will have testosterone and prostate-specific antigen (PSA) tests. Participants may be invited to NIH to give blood samples for research. Participants on this study will be followed for life.

CONDITIONS

Official Title

Precision-Based Genomics in Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed prostate cancer
  • Known germline and/or somatic variants in PIK3 and/or AKT, PALB2, BRIP1, RAD50, RAD51, RAD54, RB1, SPOP, Wnt/B-catenin pathway, CDK12, and/or MMR genes: MLH1, MSH2, MSH6, PMS2, and EPCAM and/or TMB-high (\u2265 10 mutations/megabase or blood TMB \u2265 16 mutations/megabase) or deemed an exceptional responder
  • Age 18 years or older
  • Ability to understand and willing to sign informed consent
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 11 locations

1

University of California San Diego

La Jolla, California, United States, 92093

Actively Recruiting

2

University of California San Francisco

San Francisco, California, United States, 94143

Actively Recruiting

3

NorthShore University HealthSystem

Evanston, Illinois, United States, 60201

Actively Recruiting

4

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

5

Dana Farber Cancer Institute, Boston, MA

Boston, Massachusetts, United States, 02215

Actively Recruiting

6

University of Michigan

Ann Arbor, Michigan, United States, 48109

Not Yet Recruiting

7

Memorial Sloan Kettering Cancer Center

New York, New York, United States, 10007

Actively Recruiting

8

Mount Sinai Hospital

New York, New York, United States, 10029

Not Yet Recruiting

9

Weill Cornell Medicine

New York, New York, United States, 10065

Not Yet Recruiting

10

Oregon Health Sciences University

Portland, Oregon, United States, 97239

Not Yet Recruiting

11

University of Washington

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

K

Katherine O Lee-Wisdom, R.N.

CONTACT

F

Fatima H Karzai, M.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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